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Non-covalent BTKi pirtobrutinib receives orphan drug desig

By Eo, Yun-Ho | translator Kim, Jung-Ju

23.06.08 17:30:43

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MFDS recognizes its innovativeness in treating mantle cell lymphoma

Rises as a treatment option for patients who failed treatment with existing drugs


The BTK inhibitor ¡®pirtobrutinib¡® received an orphan drug designation in Korea.

The Ministry of Food and Drug Safety recently announced that it had designated Lilly¡¯s Bruton's Tyrosine Kinase (BTK) inhibitor Jaypirca (pirtobrutinib) as an orphan drug.

The subject indication is as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma who have been previously treated with a BTK inhibitor.

The US FDA granted accelerated approval for Jaypirca in January. The drug received attention as the first non-covalent BTK inhibitor and as an alternative to patients who failed treatment with covalent BTK inhibitors like ¡®Imbruvica (ibrutinib),¡¯ ¡®Brukinsa

Eo, Yun-Ho(unkindfish@dailypharm.com)
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